Product-By-Process Claims

Product-by-process claims are certainly permitted in Canada. Whilst the Canadian Patent Act and Rules do not make any specific mention of product-by-process claims, the Canadian Manual of Patent Office Practice (which is equivalent to the United States MPEP) does consider product-by-process claims quite extensively (see sections 11.08.01 and 17.05.03). Section 55.1 of the Patent Act, although not directed to product-by-process claims, further indicates that process claims may extend to cover novel products resulting from the process.

In order to be considered allowable in Canada product-by-process claims must define a product that has novel features or distinguishing characteristics when compared with all prior products that were already known in the art. In other words, the process of manufacture of the product, as clearly set out in the claim, must somehow provide the product with distinguishing features that are conferred upon the product by virtue of the manufacturing steps.

An old piece of case law from the 1950s, Hoffman-La Roche v. Commissioner of Patents 23 C.P.R. 1, is still relevant today. The case stated that products that are already known may not be claimed by making them dependent upon a new process of manufacture. Therefore, a product-by-process claim will only be considered allowable or valid if the product generated by the method steps is inevitably distinguishable from those of the prior art.

Moreover, in order to comply with Canada’s developing case law in the realm of Utility, such novel and distinguishing features would also be required to provide the product with some special advantages over the products of the prior art. Typically, therefore, it would not be sufficient for the product, as made by a recited process, to be simply different from those products of the prior art; in order to be patentable the product made by the process must offer some new advantage, or be better in some way, when compared to the products of the prior art.

On a positive note, we know from experience that the threshold requirements for novelty and utility (as discussed above) for product-by-process claims can be quite low in Canada. Typically, the Patent Office will consider any distinguishing, useful feature or features of a product (as conferred to the product by virtue of its process of manufacture) sufficient to justify an allowable product-by-process claim.

To provide one example, consider Canadian Patent 2,538,265. This patent includes claims directed to a previously known product manufactured to a greater degree of purity (i.e. with fewer impurities) when compared to the same product made by prior methods. The greater degree of purity of the manufactured product, conferred by virtue of its method of manufacture, was determined by the Canadian patent examiner to provide sufficient justification to allow the product-by-process claims. Importantly, the successful prosecution was achievable because the novel and advantageous feature of the product was conferred upon the product by the process (in this case higher purity) and the novel features were properly disclosed in the application as filed.

Construction and interpretation of product-by-process claims in Canada

Precise construction and interpretation of product-by-process claims in Canada has been the subject of much prior debate. In 2013, however, a ruling from the Federal Court (Bayer Inc. v. Cobalt Pharmaceuticals Company 2013 FC 573) helped to clarify many of the issues.

In that case, Bayer tried to assert its claim to an extra-pure version of a known compound, manufactured by a particular method as stated in the claim. Bayer suggested that its product-by-process claim would be infringed by any equivalent compound manufactured by others that met the purity requirements of the claim, regardless of the method of manufacture employed by the competitor. Essentially, Bayer tried to argue that the method steps recited in its product-by-process claim could be ignored when construing the claim for the purposes of infringement analysis.

The Court entirely disagreed, confirming that the scope of the claim covered only products specifically manufactured in accordance with the method steps recited in the claim, taking into account the essential features and requirements of those method steps.

Infringement of Product-By-Process claims in Canada

In drawing its conclusions, the Court in Bayer Inc. v. Cobalt Pharmaceuticals Company (2013) stated that a product-by-process claim in Canada is not a product claim per se, because the manufacturing steps recited in the claim include elements that are essential to the invention. If an alleged infringer successfully omits one or such essential elements to develop their own method of manufacture of the product, to achieve a product with the same attributes or advantages as that suggested by the patentee, then the alleged infringer has realized a successful “work-around” to avoid infringement of the product-by-process claim.

Conclusions and recommendations for Canada

In conclusion, whilst product-by-process claims are permitted in Canada, they should be used with caution due to their limited scope, and because they may be more difficult to enforce.

In order to enforce a product-by-process claim in Canada, there is an onus upon the patentee to demonstrate that an allegedly infringing product was produced by the process steps recited in the product-by-process claim. The alleged infringer can avoid infringement if their product is manufactured without adherence to essential features of the method steps recited in the product-by-process claim, even if the alleged infringer’s product exhibits the same novel or advantageous attributes as the patentee’s product.

In contrast, “product per se” claims (which claim a product without mention of manufacturing steps) are generally preferred over product-by-process claims, because they are simpler to enforce and thus provide a stronger degree of protection. This is because any competitors’ products that include the essential elements of a product per se claim would be expected to infringe the claim, without need to consider or compare methods of manufacture.

Nonetheless, product-by-process claims may afford a useful form of protection for a product, especially if there is no other way to define or claim the product in question. Further, product-by-process claims in Canada may be useful and enforceable providing:

the product generated by the method is inevitably distinguishable from those of the prior art;

the product exhibits special advantages over those of the prior art; and

the method steps are recited in a broad manner, so that the method steps are difficult to work around to achieve the special advantages.

Certainly, any applicant for a Canadian patent application should consider including product-by-process claims, and attempt to achieve allowance of those claims, whenever appropriate and possible. If product-by-process scope is intended, then this should be clearly set out in the language and format of the claims.

Of course, each patent application has a unique fact situation and context that would determine whether product-by-process claims are warranted and appropriate. We would be pleased to provide more analysis and comments on a case-by-case basis.

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